Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.
PRIMARY OBJECTIVE: I. To evaluate the local control rate (LC) of treated metastatic sites in patients who undergo surgery for spinal metastasis followed by short interval postoperative spine Stereotactic Body Radiation Therapy (SBRT). SECONDARY OBJECTIVE: I. Evaluate the postoperative wound complication rate in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT. II. Determine the radiation toxicity of short-interval postoperative spine SBRT in participants. III. Determine the progression-free survival (PFS) in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT. IV. Determine the overall survival (OS) in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT. V. Evaluate the quality of life (QoL) of participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT. OUTLINE: Participants will received a short interval postoperative SBRT 3-14 days after standard of care surgery for spinal metastases. The SBRT treatment will be delivered up to five sessions in an inpatient or outpatient setting. Participants are follow-up for at month 1, 6, and 12 after SBRT, until removal from study or death, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Undergo radiation
Undergo imaging
Undergo imaging
Participant complete health related, quality of life questionnaire (HRQoL)
University of California, San Francisco
San Francisco, California, United States
Local Control (LC) Rate
Local control (LC) is defined as the time from SBRT radiotherapy to metastatic lesions (event) within the SBRT treatment field with stable or decreased size as measured by a board-certified radiologist on follow-up imaging. Participants without any documented events or death will be censored. Estimates and confidence interval will be reported using the Kaplan Meier method.
Time frame: 6 months after SBRT
Median Wound Complication Rate
Wound complication rate is defined as the rate of participants with wound complications by Centers for Disease Control and Prevention (CDC) criteria. Estimates and the 95% confidence interval will be reported using exact binomial confidence interval (CIs).
Time frame: 1 month after surgery
Proportion of Participants with Treatment-emergent Adverse Events (TrAE)
Proportion of participants with treatment-emergent adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) will be reported.
Time frame: 1 month after SBRT
Median Progression-Free Survival (PFS)
PFS is defined as the time after enrollment to radiographic progression by RECIST 1.1 criteria on MRI, CT, or Positron Emission Tomography/Computed Tomography (PETCT) at any site of disease, primary or metastatic, or any clinical evidence of progression. Tumor progression is defined as any increase in size within the radiation treatment field (determined by a radiologist), not consistent with or attributable to radiation treatment effect. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Time frame: Up to 6 months after SBRT
Median Progression-Free Survival (PFS)
PFS is defined as the time after enrollment to radiographic progression by RECIST 1.1 criteria on MRI, CT, or PETCT at any site of disease, primary or metastatic, or any clinical evidence of progression. Tumor progression is defined as any increase in size within the radiation treatment field (determined by a radiologist), not consistent with or attributable to radiation treatment effect. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Time frame: Up to 12 months after SBRT
Median Overall Survival (OS)
Overall survival is defined as the time after enrollment to death by any cause. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Time frame: Up to 6 months after SBRT
Median Overall Survival (OS)
Overall survival is defined as the time after enrollment to death by any cause. Hazard ratio and 95% confidence interval will be reported using Kaplan Meier method.
Time frame: Up to 12 months after SBRT
Median Score on the Functional Assessment of Cancer therapy, General- 7 (FACT-G7) at 1 month
The FACT-G7 is a 7-item questionnaire designed to measure general health related quality of life (HRQOL) in cancer patients. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is calculated by taking the sum of the scores x 7 divided by the number of items answered, with a total score range from 0 - 28. The higher the score, the better the HRQOL.
Time frame: 1 month
Median score on the FACT-G7 at 6 months
The FACT-G7 is a 7-item questionnaire designed to measure general health related quality of life (HRQOL) in cancer patients. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is calculated by taking the sum of the scores x 7 divided by the number of items answered, with a total score range from 0 - 28. The higher the score, the better the HRQOL.
Time frame: 6 months
Median score on the FACT-G7 at 12 months
The FACT-G7 is a 7-item questionnaire designed to measure general health related quality of life (HRQOL) in cancer patients. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is calculated by taking the sum of the scores x 7 divided by the number of items answered, with a total score range from 0 - 28. The higher the score, the better the HRQOL.
Time frame: 12 months
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